CLG-561

BFC Capital Market Update (November 2 - November 8) Market Overview Global Markets and Healthcare Sectors Post Strong Gains Amid Mixed Performance Last week, U.S. markets saw notable gains, with the Dow Jones Industrial Average up 4.6%, the S&P 500 rising 4.7%, and the Nasdaq Composite gaining 5.7%. In China, the Shanghai Composite Index and CSI 300 Index advanced by 5.5%, while the Hang Seng Index increased by 1.1%. In the healthcare sector, the U.S. Nasdaq Biotechnology Index rose 4.1%. Chinese healthcare indices also posted gains, with the SSE Health Care Index up 4.9%, the CSI Healthcare Index rising 6.4%, and the Hang Seng Healthcare Index recording a weekly increase of 2.9%. Major Biopharma Updates CARsgen Therapeutics Stock Rises 57.8% as Promising Preliminary Data for Off-the-Shelf CAR-T Therapy CT0590 Unveiled at 66th ASH Annual Meeting CARsgen Therapeutics（02171.HK, 科济药业） saw a cumulative increase of 57.8% last week. On November 6, the company announced that data for Zevor-cel (Zevorcabtagene autoleucel), CT071, and CT0590 would be presented in poster format at the 66th ASH Annual Meeting, with abstracts now available on the ASH website. Notably, this is the first human Phase I trial data for CT0590, an off-the-shelf CAR-T therapy targeting BCMA and NKG2A. Among the five enrolled participants, with a median follow-up of 16.6 months (ranging from 5.1 to 24.2 months), three patients achieved remission, including two with stringent complete response (sCR) and one with partial response (PR). Of the two patients with sCR, one with relapsed/refractory multiple myeloma (RRMM) has maintained remission for 23 months (sCR ongoing), while another with primary plasma cell leukemia (pPCL) has a duration of response (DOR) of 20 months. These preliminary results suggest that the CT0590 off-the-shelf CAR-T cell therapy is safe and capable of achieving deep and durable clinical remission. Hengrui Pharmaceuticals' Irinotecan Liposome Combination Therapy Shows 37% Reduction in Mortality Risk for Advanced Pancreatic Cancer in Phase III Trial On November 6, Hengrui Pharmaceuticals（600276.SH,恒瑞医药） announced results from a randomized, double-blind, parallel-controlled, multicenter Phase III clinical trial of Irinotecan Liposome (II) combined with 5-FU/LV as a second-line treatment for locally advanced or metastatic pancreatic cancer in patients who had previously failed gemcitabine treatment. The results indicated that the Irinotecan Liposome (II) combination therapy reduced the risk of death by 37% compared to the control group in pancreatic cancer patients. Business Development Updates In the past week, PharmaEngine secured Taiwan distribution rights for LIPORAXEL from Shanghai RMX Biopharma. Novo Nordisk partnered with Ascendis Pharma to use TransCon technology for semaglutide and other therapies. Royalty Pharma acquired U.S. royalty rights for Syndax's Niktimvo against GVHD. Nobelpharma licensed Y-mAbs' Danyelza for neuroblastoma in Japan. DRI Healthcare acquired global royalty rights for KalVista's sebetralstat for HAE. Nxera and Antiverse are collaborating on AI-based GPCR antibodies. Aditum Bio and Leads Biolabs formed Oblenio Bio for a tri-specific T-cell engager. Santen gained rights to Arctic Vision’s ARVN-001 for eye conditions in China. Zhida Pharma secured an option for Vivesto’s Apealea in Greater China. PharmaEngine to distribute Shanghai RMX Biopharma’s LIPORAXEL in China Nov 4, 2024 – PharmaEngine and Shanghai RMX Biopharma (a subsidiary of Haihe Biopharma) entered into an exclusive distribution agreement for LIPORAXEL (paclitaxel oral solution) in the Taiwan market. Novo Nordisk to use Ascendis Pharma' TransCon Technology to develop, manufacture and commercialize therapeutics including Semaglutide for metabolic diseases and cardiovascular diseases worldwide Nov 4, 2024 – Novo Nordisk entered into an exclusive worldwide research and development collaboration and license agreement with Ascendis Pharma for TransCon technology to develop, manufacture and commercialize therapeutics including semaglutide , by reducing their dosing frequency for the treatment of metabolic diseases and a product-by-product exclusive license in cardiovascular diseases. Royalty Pharma to acquire royalty rights of Syndax's Niktimvo against GVHD in the US Nov 4, 2024 –Royalty Pharma entered into a synthetic royalty funding agreement for Syndax Pharmaceuticals ' Niktimvo (axatilimab) against chronic graft-versus-host disease (GVHD) in the United States. Nobelpharma to commercialize Y mAbs Therapeutics' Danyelza for relapsed/refractory high risk neuroblastoma in Japan Nov 4, 2024 –Nobelpharma entered into an exclusive license and distribution agreement with Y-mAbs Therapeutics to commercialize Danyelza for the treatment of relapsed/refractory high risk neuroblastoma in Japan. DRI Healthcare to acquire royalty rights of KalVista's sebetralstat against HAE worldwide Nov 4, 2024 – DRI Healthcare signed a synthetic royalty financing agreement to acquire rights of KalVista Pharmaceuticals ' sebetralstat against hereditary angioedema (HAE) worldwide. Nxera and Antiverse to design and globally commercialize AI based antibodies for GPCRs Nov 5, 2024 – Nxera agreed with Antiverse to design and globally commercialize AI based antibodies for G-protein coupled receptors (GPCRs). Aditum Bio and Leads Biolabs Announce the Formation of Oblenio Bio to Develop a Tri-Specific T-Cell Engager for Autoimmune Disorders Nov 7, 2024 – Aditum Bio and Leads Biolabs today announced the formation of Oblenio Bio, which is being formed in conjunction with an exclusive option and license agreement to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody for autoimmune diseases. Aditum Bio will fund Oblenio Bio and the parties will collaborate to rapidly bring LBL-051 into clinical studies. Santen to commercialize Arctic Vision' ARVN-001 for UME and other ophthalmic indications in China excluding Taiwan, Hong Kong and Macau Nov 7, 2024 – Santen signed an agreement with Arctic Vision to commercialize ARVN-001 for uveitic macular edema (UME) and certain other ophthalmic indications in China excluding Taiwan, Hong Kong and Macau. Zhida Pharma to sign an option to develop and commercialize Vivesto’s Apealea for ovarian cancer in China, Hong Kong, Macau and Taiwan Nov 7, 2024 –Zhejiang Zhida Pharmaceutical signed an exclusive license option agreement with Vivesto to develop and commercialize anticancer product Apealea (paclitaxel micellar) for ovarian cancer in China, Hong Kong, Macau and Taiwan. References： 1.https://www.carsgen.com/en/news/carsgen-to-present-zevor-cel-ct071-and-ct0590-at-ash-2024-annual-congress/ 2.https://www.hengrui.com/media/detail-665.html